Events

Alerta De Seguridad para ARCHITECT TOXO IgG REAGENT KIT - Registration 80146501513 - Lots Affected: 15070LI00 and 15070LI01.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATÓRIOS DO BRASIL LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1160
  • Fecha
    2012-08-10
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    A false reactive result for the Toxo IgG test would lead to a misdiagnosis that the patient would be immune to Toxoplasmosis. In the case of a pregnant patient, this type of diagnosis could avoid monitoring during pregnancy, which would lead to loss of early detection of infection and subsequent therapeutic intervention. There is potential for occurrence of results from falsely reactive patients at an estimated incidence of 2.65%. According to the Company's Action Plan, the term for this Field Action is OUT / 2012. Anvisa accompanies this Action.
  • Causa
    Abbott laboratories has identified that affected batches of this reagent are exhibiting reduced specificity, which may yield higher iu / ml values, leading to a greater number of gray zone or reactive results.
  • Acción
    Verify that you are using or have the affected batches of the ARCHITECT Toxo IgG test stocked, discontinue use immediately, segregate the kits as they will be collected and replaced by Abbott Laboratories.

Device

ARCHITECT TOXO IgG REAGENT KIT - Registration 80146501513 - Lots Affected: 15070LI00 and 15070LI01.

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA